REACH: RWE Retrospective Study to Evaluate Cenobamate Impact on Health Care Resource Utilization

Retrospective Evaluation of Cenobamate's Health Care Resources Utilization (HCRU) in the Management of Uncontrolled Focal Onset Seizures- A Retrospective, Chart Review Study

The Study is an observational, retrospective study which aim is to assess cenobamate's healthcare resources utilization (HCRU) in the management of uncontrolled focal onset seizures. The amin objective is to compare the resource utilization before and after the use of cenobamate. Data from medical charts will be used and inserted into the eCRF from which the analyses will be conducted. Data from 200 patients from 10 sites in 5 countries are included.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy With Uncontrolled Focal-onset Seizures

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Lars Nicklasson; Phone Number: +46 702528077; Email: Lars.nicklasson@angelinipharma.com

Study Locations

• Germany
  • Germany
    • Freiburg im Breisgau, Germany, Germany
      • Not yet recruiting
      • Epilepsiezentrums am Neurozentrum des Universitätsklinikum Freiburg
      • Contact: Andreas Schulze-Bonhage
    • Hamburg, Germany, Germany
      • Not yet recruiting
      • Epileptologicum
      • Contact: Patrick House
    • Kork, Germany, Germany
      • Not yet recruiting
      • Diakonie Kork, Epilepsiezentrum
      • Contact: Bernhard Steinhoff
• Netherlands
  • Netherlands
    • Heeze, Netherlands, Netherlands
      • Not yet recruiting
      • Kempenhaeghe - Academisch Centrum voor Epilepsie
      • Contact: H.J.M. Marian Majoie
• Spain
  • Spain
    • Barcelona, Spain, Spain
      • Recruiting
      • Epilepsy Unit - Neurology Department Valle de Hebron Hospital
      • Contact: Manuel Toledo Argany
    • Madrid, Spain, Spain
      • Recruiting
      • Epilepsy Unit of the Neurology Department of the Hospital Clínico San Carlos
      • Contact: Irene Garcia Morales
    • Valencia, Spain, Spain
      • Recruiting
      • Consorcio Hosp. General Universitario Valencia
      • Contact: Ascensión Castillo Ruiz
• Switzerland
  • Switzerland
    • Zurich, Switzerland, Switzerland
      • Recruiting
      • Department of Neurology, University Hospital Zurich
      • Contact: Marian Galovic
• United Kingdom
  • UK
    • Glasgow, UK, United Kingdom
      • Recruiting
      • Institute of Neurosciences NHS Greater Glasgow and Clyde
      • Contact: Craig Heath
    • Wolverhampton, UK, United Kingdom
      • Recruiting
      • Epilepsies - The Royal Wolverhampton NHS Trust
      • Contact: Phil Tittensor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients affected by epilepsy with focal-onset seizures not adequately controlled after 2 or more anti-seizure medications (ASMs), due to efficacy or tolerability issues, who start a treatment with cenobamate as an adjunctive therapy (according to SmPC), in real world setting, and have at least 6 months of data on treatment and healthcare resources utilization (HCRU) (if any) prior to cenobamate starting date.

Description

Inclusion Criteria:

1. Male and female patients of any ethnic origin ≥18 years old at index date;
2. Patients with a diagnosis of epilepsy with uncontrolled focal-onset seizures despite the previous treatment with from 2 to 5 ASMs who started treatment with cenobamate at index date;
3. Patients presenting at least 1 seizure a month in the last 6 months prior to index date;
4. Patients with at least 6 months of data coverage in the medical records prior to the index date;
5. Patients with at least 12 months of data in the medical records after index date (with a maximum interval between data of 6 months).
6. Patients who give the consent to the processing of personal data according to the General Data Protection Regulation (GDPR) and/or other applicable local regulation.

Exclusion Criteria:

1. Patients who meet any of the contraindications to the administration of adjunctive ASMs according to their approved SmPC;
2. Patients who started cenobamate within an EAP;
3. Progressive neurological disease, including degenerative CNS diseases and/or progressive brain tumors;
4. Patients with specific syndrome (e.g. LGS and Dravet);
5. Pregnancy or lactation;
6. Patients without self-judgement ability;
7. Patients with substance and alcohol abuse or dependence (except for caffeine and nicotine);
8. Patients participating in any pharmacological or nonpharmacological interventional study starting from 6 months before the index date.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Adult patients affected by epilepsy with focal-onset seizures; Adult patients affected by epilepsy with focal-onset seizures not adequately controlled after 2 or more ASMs (anti-seizure medications), due to efficacy or tolerability issues, who start a treatment with cenobamate as an adjunctive therapy (according to SmPC), in real world setting, and have at least 6 months of data on treatment and HCRU (if any) prior to cenobamate starting date.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines.	To assess the impact of cenobamate used as adjunctive therapy on epilepsy-related HCRU, will be collected the number of epilepsy/epilepsy treatment-related hospitalizations during all the observation period	0-12 months
Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines.	To assess the impact of cenobamate used as adjunctive therapy on epilepsy-related HCRU,will be collected the length of epilepsy/epilepsy treatment-related hospitalizations during all the observation period	0-12 months
Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines	To assess the impact of cenobamate used as adjunctive therapy on epilepsy-related HCRU will be collected the number of epilepsy/epilepsy treatment-related outpatient visits (OP) during all the observation period	0-12 months
Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines	To assess the impact of cenobamate used as adjunctive therapy on epilepsy-related HCRU will be collected the number of epilepsy/epilepsy treatment-related emergency room (ER) visits;	0-12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs)	To assess the impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs), the following data will be recorded: Switch/add-on of other ASMs	0-12 months
Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs)	To assess the impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs), the following data will be recorded: Changes in the dose of co-ASMs	0-12 months
Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs)	To assess the impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs), the following data will be recorded: Changes in the number of co-ASMs	0-12 months
Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs)	To assess the impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs), the following data will be recorded: Time to discontinuation of ASMs	0-12 months
Impact of cenobamate used as adjunctive therapy on epilepsy-related emergency and medical care	To evaluate the impact of cenobamate used as adjunctive therapy on epilepsy-related emergency and medical care, the number of epilepsy/epilepsy treatment related emergency care, ambulance use, the number of outpatient visits with neurologists, and the number of epilepsy specialist nurses' intervention will be collected;	0-12 months
Effectiveness of cenobamate used as adjunctive therapy	To evaluate the effectiveness of cenobamate used as adjunctive therapy, seizure frequency at baseline and at routinely scheduled follow-up visits, till the end of observation will be collected. For comparability, seizure frequency will be extrapolated per month (28 days);	0-12 months
Impact of cenobamate used as adjunctive therapy on epilepsy-related surgery	To assess the impact of cenobamate used as adjunctive therapy on epilepsy-related surgery the following data will be collected: the number of epilepsy-related surgery (how many patients initiated cenobamate while they were in waiting list or post-surgical intervention, i.e. surgical failure);; the number of hospitalizations due to surgery related to epilepsy (e.g. fractures due to falls);; the number of Intensive Care Unit (ICU) visits;	0-12 months
Impact of cenobamate used as adjunctive therapy on comorbidity-related healthcare resources utilization (HCRU)	To evaluate the impact of cenobamate used as adjunctive therapy on comorbidity-related HCRU, the following data will be collected: Number and length of hospitalizations of all-cause inpatient visits,; Number of ER visits,; Number of outpatient visits. All-cause HCRU will be defined as HCRU due to any cause;	0-12 months
Impact of cenobamate used as adjunctive therapy on phone calls/virtual interventions	To evaluate the impact of cenobamate used as adjunctive therapy on phone calls/virtual interventions, the number of phone calls/virtual interventions will be collected.	0-12 months
Safety of cenobamate used as adjunctive therapy	To evaluate safety of cenobamate used as adjunctive therapy, the number, type and severity of, adverse events, adverse drug reactions will be collected. Moreover, changes in the number, type, dose of concomitant medications other than anti-seizure medications will be collected over the duration of the study.	0-12 months

Collaborators and Investigators

• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A
• Collaborators: 1Med

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: April 1, 2025
• First Submitted That Met QC Criteria: April 9, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: October 1, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Epilepsy; anti-seizure medications
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: 169(A)AV23432

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No